Urinary incontinence treatment with wireless energy supply

ABSTRACT

A urinary incontinence treatment apparatus comprises an operable restriction device ( 4 ) to be implanted in a patient for engaging the urethra ( 66 ) or urine bladder, to form a restricted urine passageway in the urethra or urine bladder. The restriction device is operable to change the restriction of the urine passageway. An energy transmission device ( 10 ) is provided for wireless transmission of energy from outside the patient&#39;s body to inside the patient&#39;s body for use in connection with the operation of the restriction device including enlarging or restricting the urine passageway.

This application is the U.S. National Phase of International ApplicationNo. PCT/SE01/00270, filed Feb. 9, 2001, which designated the U.S., andwhich claims the benefit of Provisional application Ser. No. 60/181,469,filed Feb. 10, 2000 and Provisional application Ser. No. 60/181,550,filed Feb. 10, 2000.

The present invention relates to a urinary incontinence treatmentapparatus comprising an operable restriction device implantable in apatient, who suffers from urinary incontinence, for engaging the urethraor urine bladder, to form a restricted urine passageway in the urethraor urine bladder. The restriction device is operable to change therestriction of the urine passageway, i.e. to close and enlarge the urinepassageway. The term “patient” includes an animal or a human being.

Urine incontinence is a widespread problem. Many people are helpedthrough training of the muscles in the pelvic floor but too many havesevere problems with urine leakage. Many different solutions to thisproblem have been tried. For example, there is a prior manually operatedurine incontinence treatment apparatus having an artificial hydraulicsphincter device engaging the urethra and connected to an elasticreservoir implanted in the scrotum or in the region of the labia major.A disadvantage of this prior apparatus is that over time hard fibrosisis developed around the reservoir, which may cause malfunction ofpumping components. Furthermore, it is a rather complicated task tomanually squeeze the elastic implanted reservoir to pump hydraulic fluidto open the sphincter device when the patient needs to urinate. Inparticular women can get their fingers wet. The created fibrosis willsooner or later become a hard fibroid layer, which may make it even moredifficult to pump the reservoir. Yet a further disadvantage is that theuse of hydraulic fluid always entails a risk of fluid leaking fromimplanted hydraulic components.

A prior hydraulic apparatus designed to compress the urethra isdisclosed in U.S. Pat. No. 5,520,606. A prosthetic sphincter with aninflatable cuff, which surrounds the urethra or encloses it on twosides, is disclosed in for example U.S. Pat. Nos. 4,571,749 and4,222,377. U.S. Pat. No. 4,969,474 discloses a hydraulic method fortreating both men and women with urinary incontinence problems in thesame way. The apparatus of U.S. Pat. No. 4,969,474 includes a reservoircontaining fluid and an inflatable compression means designed tocompress urethra without risking tissue loss or necrosis to occur. Anartificial hydraulically operated urethra sphincter employing anexternal magnet to achieve closure of the urethra cuff is disclosed inU.S. Pat. No. 5,562,598.

A prior mechanical prosthetic sphincter disclosed in U.S. Pat. No.4,619,245 comprises a manually controllable actuating component forimplanting at a convenient location in the patient's body.

The object of the present invention is to provide a new convenienturinary incontinence treatment apparatus, the performance of which maybe affected by the patient at any time after operation, in particularwhen various needs arise over the course of a day, so that the patientsubstantially always is satisfied or comfortable.

This object is achieved by a urinary incontinence treatment apparatus ofthe kind stated initially characterised by an energy transmission devicefor wireless transmission of energy from outside the patient's body toinside the patient's body for use in connection with the operation ofthe restriction device including enlarging or restricting the urinepassageway, when the restriction device is implanted.

As a result, the advantage is achieved that the urinary incontinencetreatment apparatus of the invention provides simple and effectiveenergy transmission that ensures long reliable function of theapparatus, possibly for the rest of the patient's life.

Generally, the apparatus comprises an energy transforming deviceimplantable in the patient for transforming the energy wirelesslytransmitted by the energy transmission device from a first form into asecond form, preferably different than the first form.

The energy transforming device may comprise at least one semiconductortype of component or a circuitry of such semiconductor components. Thesemiconductor component may comprise a transistor or microchip orsimilar electronic components. However, the semiconductor component maynot comprise rectifying diodes.

In accordance with a main embodiment of the invention, the energytransforming device comprises at least one element having a positiveregion and a negative region and adapted to create an energy fieldbetween the positive and negative regions when exposed to the energy ofthe first form transmitted by the energy transmission device, so thatthe energy field provides the energy of the second form. Typically, theabove-mentioned semiconductor component may include such an element.

In accordance with a preferred embodiment of the invention, the elementcomprises an electrical junction element capable of inducing an electricfield between the positive and negative regions when exposed to theenergy of the first form transmitted by the energy transmission device,whereby the energy of the second form comprises electric energy.

Consequently, the restriction device suitably is electrically operated,whereby the positive and negative regions of the electrical junctionelement supply electric energy for the operation of the restrictiondevice. The apparatus suitably comprises implantable electric conductorsconnected to the positive and negative regions of the electricaljunction element, whereby the electrical junction element is capable ofsupplying an electric current, such as a direct current, a pulsatingdirect current, a combination of a direct and pulsating direct current,an alternating current or a combination of a direct and alternatingcurrent, via the conductors. Furthermore, the electrical junctionelement may be capable of supplying a frequency, amplitude, or frequencyand amplitude modulated analog, digital, or a combination of analog anddigital signal, which is used in connection with control of therestriction device.

The element, preferably in the form of an electrical semiconductorjunction element, should be designed to generate an output currentexceeding 1 μA when exposed to the energy of the first form transmittedby the energy transmission device. Suitably the electrical junctionelement forms a flat and thin sheet and has a volume of less than 2000cm³ to be suited for subcutaneous implantation, so that the electricaljunction element can be located just behind the skin of the patient.Alternatively, it would be possible to implant the element in the thoraxor cephalic region of the patient, or in an orifice of the patient'sbody and under the mucosa or intraluminar outside the mucosa of theorifice. Of course, all the components of the energy transforming deviceincluding the electrical junction element in contact with the patient'sbody should be of biocompatible material.

For in vitro appliances, a particular type of an electricalsemiconductor junction element has been commonly used, namely aso-called p-n (positive/negative) junction element, typically in theform of solar cells. A solar cell transfers solar energy in the form ofvisible light into electric energy in the form of direct current. Forexample, a p-n junction element may comprise two layers ofsemiconductor, one p-type (positive) and the other n-type (negative),sandwiched together to form a “p-n junction”. This p-n junction inducesan electric field across the element when absorbing quanta of light(photons).

To be more precise, the quanta of light transfer their energy to some ofthe semiconductor's electrons, which are then able to move about throughthe material. For each such negatively charged electron, a correspondingpositive charge—a “hole”—is created. In an ordinary semiconductor, theseelectrons and holes recombine after a short time and their energy iswasted as heat. However, when the electrons and holes are swept acrossthe p-n junction in opposite directions by the action of the electricfield, the separation of charge induces a voltage across the p-njunction element. By connecting the p-n junction element to an externalcircuit, the electrons are able to flow thereby creating a current.

Surprisingly, it has been proved that although both the skin andsubcutis absorb energy from an external light beam directed against theskin portion behind which a properly designed p-n junction element islocated, the light energy transmitted through the skin can induce acurrent from the p-n junction element strong enough (minimum 1 μA) toenable the operation of the electrically operated restriction device.Thus, such a p-n junction element is now for the first time used for invivo applications.

The apparatus may comprise an implantable pulse generator for generatingelectrical pulses from the energy of the second form produced by theenergy field.

Generally, the energy transforming device is adapted to transform theenergy of the first form directly or indirectly into the energy of thesecond form.

In accordance with a preferred embodiment of the invention, the energyof the second form comprises electric energy and the energy transformingdevice comprises a capacitor, which may be adapted to produce electricpulses from the transformed electric energy. Preferably, the capacitormay be adapted to produce the pulses as the energy transforming devicetransforms the energy of the first form transmitted by the energytransmission device into the electric energy of the second form. Thecapacitor should be small to facilitate implantation thereof; i.e. itscapacity may not be more than 0,1 μF.

The apparatus may comprise an implantable stabiliser for stabilising theenergy of the second form. Where the energy of the second form compriseselectric current the stabiliser may comprise at least one capacitor ofthe type described above.

In most embodiments of the invention, the apparatus comprisesimplantable electrical components. Where the electrical componentsinclude a capacitor of the type described above or an accumulator, atleast one, preferably a single, voltage level guard may advantageouslybe provided, wherein the charge and discharge of the capacitor oraccumulator is controlled by use of the voltage level guard. As aresult, there is no need for any implanted current detector and/orcharge level detector for the control of the capacitor, which makes theapparatus simple and reliable.

In a particular embodiment of the invention, the wireless energy of thefirst form comprises sound waves and the energy of the second formcomprises electric energy, wherein the energy transforming device isadapted to directly transform the sound waves into electric energy.

The apparatus may comprise an implantable motor or pump for operatingthe restriction device, wherein the motor or pump is powered by thetransformed energy.

In accordance with a main aspect of the invention, the energytransmission device may be adapted to transmit wireless energy fordirect use in connection with the operation of the restriction device,as the wireless energy is being transmitted. The advantage of directlyusing energy as it is transmitted is that the apparatus can be of a verysimple design and the few components involved makes the apparatusextremely reliable. For example, the energy transmission device may beadapted to directly power the motor or pump with wireless energy. Thewireless energy may comprise a magnetic field or electromagnetic waves,suitably in the form of a signal, for direct power of the motor or pump.All the various functions of the motor and associated componentsdescribed in the present specification may be used where applicable.

As an alternative to the above-noted main aspect of the invention, theenergy transforming device may be adapted to supply the energy of thesecond form for direct use in connection with the operation of therestriction device, as the energy of the first form is being transformedinto the energy of the second form. Consequently, the energytransforming device may be adapted to directly power the motor or pumpwith the energy of the second form.

Generally, the energy transforming device directly operates therestriction device with the energy of the second form in a non-magnetic,non-thermal or non-mechanical manner.

Where the apparatus comprises a motor, which may be adapted to directlyor intermittently operate the restriction device, the energytransforming device may power the motor with the energy of the secondform. Suitably, the restriction device is operable to perform areversible function and the motor is capable of reversing said function.

In accordance with another embodiment of the invention, the restrictiondevice comprises a hydraulic restriction device, and the apparatuscomprises an implantable pump for operating the hydraulic restrictiondevice, wherein the energy transforming device supplies the energy ofthe second form for driving the pump. Preferably, the pump is not aplunger type of pump, but may comprise a peristaltic or membrane pump.

The energy transforming device preferably is capable of generating asthe energy of the second form a current exceeding 1 μA, whentransferring the energy of the first form transmitted by the energytransmission device.

The apparatus may comprise an implantable adjustment device foradjusting the restriction device to change the restriction of the urinepassageway. In accordance with a first alternative the adjustment deviceis adapted to mechanically adjust the restriction device. In accordancewith a second alternative the adjustment device is adapted tohydraulically adjust the restriction device by using implanted hydraulicmeans. Such hydraulic means may not use hydraulic fluid of the kindhaving a viscosity that substantially increases when exposed to heat ora magnetic field.

The apparatus of the present invention is not limited to the use ofvisible light for the wireless transmission of energy. Thus, inaccordance with a broad aspect of the invention, the energy transmissiondevice transmits energy by at least one wireless signal, preferablycontaining radiant energy.

The wireless signal may comprises a wave signal, for example anelectromagnetic wave signal, such as an infrared light signal, a visiblelight signal, an ultra violet light signal, a laser signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal, and a gammaradiation signal. Where applicable, one or more of the above signals maybe combined. Alternatively, the wave signal may comprise a sound wavesignal, such as an ultrasonic signal. Generally, the wireless signal maycomprise a digital, analog or a digital and analog signal.

The energy of the first form transmitted by the energy transmissiondevice may comprise an electric or magnetic field transmitted in pulses,for example digital pulses. Furthermore, the energy transforming devicemay transform the energy of the first form, which may comprise polarisedenergy, into a direct current, pulsating direct current, a combinationof a direct and pulsating direct current, an alternating current or acombination of a direct and alternating current. Alternatively, theenergy of the first form may comprise kinetic energy.

The energy of the second form may comprise a frequency, amplitude orfrequency and amplitude modulated analog, digital or combined analog anddigital signal.

The restriction device may be non-inflatable, i.e. with no hydraulicfluid involved for the adjustments of the restriction device. Thiseliminates problems with fluid leaking from the restriction device.

The apparatus suitably comprises implantable electric conductorsconnected to the energy transforming device, whereby the energytransforming device is capable of supplying an electric current, such asdirect current, a pulsating direct current, a combination of a directand pulsating direct current, an alternating current or a combination ofa direct and alternating current, via the conductors. Furthermore, theenergy transforming device may be capable of supplying a frequency,amplitude, or frequency and amplitude modulated analog, digital, or acombination of analog and digital signal, which is used in connectionwith control of the restriction device.

In accordance with a main embodiment of the invention, the apparatuscomprises an implantable operation device for operating the restrictiondevice and a control device for controlling the operation device,wherein the energy transforming device powers the operation device withthe energy of the second form. The operation device preferably comprisesa motor, for example an electric linear motor or an electric rotarymotor that is controlled by the control device to rotate a desirednumber of revolutions. Optionally, an implantable gearing may beconnected to the motor. The electric motor may have electricallyconductive parts made of plastics. Alternatively, the motor may comprisea hydraulic or pneumatic fluid motor, wherein the control devicecontrols the fluid flow through the fluid motor. Motors currentlyavailable on the market are getting smaller and smaller. Furthermore,there is a great variety of control methods and miniaturised controlequipment available. For example, the number of revolutions of a rotarymotor may be analysed by a Hall-element just a few mm in size.

In accordance with another embodiment of the invention, the restrictiondevice comprises hydraulic means and the operation device is adapted toconduct a hydraulic fluid in the hydraulic means. The operation devicecomprises a fluid conduit connected to the hydraulic means of therestriction device, and a reservoir for fluid, wherein the reservoirforms part of the conduit. The reservoir may form a fluid chamber with avariable volume, and the operation device may be adapted to distributefluid from the chamber to the hydraulic means of the restriction deviceby reduction of the volume of the chamber and to withdraw fluid from thehydraulic means to the chamber by expansion of the volume of thechamber. The operation device suitably comprises an implantable motorused for reducing and expanding the volume of the chamber. Also, theoperation device may comprise a pump for pumping the hydraulic fluid inthe hydraulic means of the restriction device. All of the hydrauliccomponents involved are preferably devoid of any non-return valve. Thisis of great advantage, because with valves involved there is always arisk of malfunction due to improperly working valves, especially whenlong time periods passes between valve operations.

The control device may be adapted to reverse the operation device byshifting polarity of the energy of the second form. Where the operationdevice comprises an electric motor the energy of the second formsuitably comprises electric energy.

In accordance with yet another embodiment of the invention, therestriction device is operable to perform a reversible function, such asenlarging and restricting the urine passageway, and there is a reversingdevice implanted in the patient for reversing the function performed bythe restriction device. Such a reversing function preferably involvesenlarging and restricting the urine passageway by the restrictiondevice, suitably in a stepless manner. In this connection, the controldevice suitably controls the reversing device, which may include aswitch, to reverse the function performed by the restriction device. Thereversing device may comprise hydraulic means including a valve forshifting the flow direction of a fluid in the hydraulic means.Alternatively, the reversing device may comprise a mechanical reversingdevice, such as a switch or a gearbox.

Where the reversing device comprises a switch it may be operable by theenergy of the second form. In this case, the control device suitablycontrols the operation of the switch by shifting polarity of the energyof the second form supplied to the switch. The switch may comprise anelectric switch and the source of energy may supply electric energy forthe operation of the switch.

In accordance with an advantageous embodiment of the invention, theapparatus further comprises an energy storage device implanted in thepatient for storing the energy of the second form and for supplyingenergy in connection with the operation of the restriction device. Theimplanted energy storage device preferably comprises an electric sourceof energy, such as an accumulator, a rechargeable battery or acombination of an accumulator and rechargeable battery.

The apparatus may further comprise a switch implantable in the patientfor switching the operation of the restriction device and a source ofenergy implantable in the patient. This embodiment is particularlysuited for applications where the energy transmission efficiency of theapparatus is insufficient, i.e. where the implanted restriction deviceis to perform more advanced operations. Such a source of energypreferably is a battery. Alternatively, the source of energy is anaccumulator that also may store the energy of the second form.

In accordance with a first alternative, the switch is operated by theenergy of the second form supplied by the energy storage device toswitch from an off mode, in which the source of energy is not in use, toan on mode, in which the source of energy supplies energy for theoperation of the restriction device. In this case, the implanted sourceof energy may comprise a battery, preferably having a lifetime of atleast 10 years, or an accumulator. However, other kinds of sources arealso conceivable, such as a nuclear source of energy or a chemicalsource of energy (fuel cells).

In accordance with a second alternative, the apparatus further comprisesa remote control for controlling the supply of energy of the implantedsource of energy, wherein the switch is operated by the energy of thesecond form supplied by the energy storage device to switch from an offmode, in which the remote control is prevented from controlling thesource of energy and the source of energy is not in use, to a standbymode, in which the remote control is permitted to control the source ofenergy to supply energy for the operation of the restriction device.

In accordance with a third alternative, the energy storage device isomitted, wherein the switch is operated by the energy of the second formsupplied by the energy transforming device to switch from an off mode,in which the remote control is prevented from controlling the source ofenergy and the source of energy is not in use, to a standby mode, inwhich the remote control is permitted to control the source of energy tosupply energy for the operation of the restriction device.

In accordance with a fourth alternative, also the remote control isomitted, wherein the switch is operated by the energy of the second formsupplied by the energy transforming device to switch from an off mode,in which the source of energy is not in use, to an on mode, in which thesource of energy supplies energy for the operation of the restrictiondevice. Where applicable, in the described embodiments the switch mayswitch when the energy transmission device is transmitting wirelessenergy, preferably while the transferred energy of the second form isstabilised by an implanted capacitor, which may temporarily (for a fewseconds) store the energy of the second form.

In the above noted third and fourth alternatives, the energytransmission device may be substituted for the energy transformingdevice, whereby the switch is operated by the energy of the first form.

The switch mentioned above may comprise an electronic switch or, whereapplicable, a mechanical switch.

The advantage of using a switch above all is increased control safety;i.e. interfering signals in the patient's surroundings cannot affect theimplanted restriction device. Furthermore, the lifetime of the implantedsource of energy will be significantly prolonged, since the energyconsumption of the apparatus will be reduced to a minimum. During theabove-mentioned standby mode, the remote control uses energy from theimplanted source of energy. By means of the energy transmission deviceenergy may be transmitted to activate the switch to connect theimplanted source of energy only when energy is required in connectionwith the operation of the restriction device.

All of the above embodiments may be combined with at least oneimplantable sensor for sensing at least one physical parameter of thepatient, wherein the control device may control the restriction devicein response to signals from the sensor. For example, the sensor maycomprise a pressure sensor for directly or indirectly sensing thepressure against the restriction device, human tissue or in the urinepassageway, or the pressure against the urethra or the lower part of theurine bladder. The control device may comprise an internal control unitimplanted in the patient for, preferably directly, controlling therestriction device in response to signals from the sensor. In responseto signals from the sensor, for example pressure, the patient's positionor any other important physical parameter, the internal control unit maysend information thereon to outside the patient's body. The control unitmay also automatically control the restriction device in response tosignals from the sensor. For example, the control unit may control therestriction device to further restrict the urine passageway in responseto the sensor sensing that the patient is lying, or enlarge the urinepassageway in response to the sensor sensing an abnormally high pressureagainst the restriction device.

Alternatively, the control device may comprise an external control unitoutside the patient's body for, suitably directly, controlling therestriction device in response to signals from the sensor. The externalcontrol unit may store information on the physical parameter sensed bythe sensor and may be manually operated to control the restrictiondevice based on the stored information. In addition, there may be atleast one implantable sender for sending information on the physicalparameter sensed by the sensor.

An external data communicator may be provided outside the patient's bodyand an internal data communicator may be implanted in the patient forcommunicating with the external communicator. The internal communicatormay feed data related to the patient, or related to the restrictiondevice, back to the external communicator. Alternatively or incombination, the external communicator may feed data to the internalcommunicator. The internal communicator may suitably feed data relatedto at least one physical signal of the patient.

The apparatus may further comprise an implantable programmable controlunit for controlling the restriction device, preferably over time inaccordance with an activity schedule program. This will advance theapparatus and make possible an adaptation of the apparatus to theindividual patients.

Many of the above embodiments are suitably remote controlled. Thus, theapparatus advantageously comprises a wireless remote controltransmitting at least one wireless control signal for controlling therestriction device. With such a remote control it will be possible toadapt the function of the apparatus to the patient's need in a dailybasis, which is beneficial with respect to the treatment of the patient.The control signal may comprise a frequency, amplitude or frequency oramplitude modulated signal. Furthermore, the control signal may comprisean analog or a digital signal, or a combination of an analog and digitalsignal.

The wireless remote control may be capable of obtaining information onthe condition of the implanted restriction device and of controlling therestriction device in response to the information. Also, The remotecontrol may be capable of sending information related to the restrictiondevice from inside the patient's body to the outside thereof.

In a particular embodiment of the invention, the wireless remote controlcomprises at least one external signal transmitter or transceiver and atleast one internal signal receiver or transceiver implantable in thepatient. In another particular embodiment of the invention, the wirelessremote control comprises at least one external signal receiver ortransceiver and at least one internal signal transmitter or transceiverimplantable in the patient.

The wireless remote control may transmit a carrier signal for carryingthe control signal, wherein the carrier signal is frequency, amplitudeor frequency and amplitude modulated. The carrier signal may alsocomprise digital, analog or a combination of digital and analog signals.Such signals may comprise wave signals. Also the control signal usedwith the carrier signal may be frequency, amplitude or frequency andamplitude modulated, and be digital, analog or combined digital andanalog.

The control signal may comprise a wave signal, for example, a sound wavesignal, such as an ultrasound wave signal, an electromagnetic wavesignal, such as an infrared light signal, a visible light signal, anultra violet light signal, a laser signal, a micro wave signal, a radiowave signal, an x-ray radiation signal, or a gamma radiation signal.Where applicable, two or more of the above signals may be combined.

The control signal may be digital or analog, and may comprise anelectric or magnetic field. Suitably, the wireless remote control maytransmit an electromagnetic carrier wave signal for carrying the digitalor analog control signal. For example, use of an analog carrier wavesignal carrying a digital control signal would give safe communication.The control signal may be transmitted in pulses by the wireless remotecontrol.

The energy transmission device may function different from or similar tothe energy transforming device. For example, the energy transmission andtransforming devices function differently when the energy transmissiondevice comprises a coil used for transmitting the energy of the firstform and the energy transforming device comprises an electrical junctionelement for transforming the transmitted energy into the energy of thesecond form. The energy transmission and transforming devices functionsimilar to each other when the energy transmission device comprises acoil used for transmitting the energy of the first form and the energytransforming device also comprises a coil for transforming thetransmitted energy into the energy of the second form.

In accordance with an alternative embodiment of the invention, theapparatus comprises an activatable source of energy implantable in thepatient, wherein the source of energy is activated by wireless energytransmitted by the energy transmission device, to supply energy which isused in connection with the operation of the restriction device.

The implantable restriction device suitably is embedded in a soft orgel-like material. For example, a silicone material having hardness lessthan 20 Shore.

All the above described various components, such as the motor, pump andcapacitor, may be combined in the different embodiments whereapplicable. Also the various functions described in connection with theabove embodiments of the invention may be used in differentapplications, where applicable.

All the various ways of transferring, transforming and controllingenergy presented in the present specification may be practised by usingall of the various components and solutions described.

The present invention also provides an implanting method, comprising thesteps of providing a urinary incontinence treatment apparatus describedabove, cutting an opening in a patient's mucosa in an orifice of thepatient's body, and implanting the energy transforming device in thepatient's body through the opening.

There is also provided a laparascopical implanting method, in accordancewith a first alternative, comprising the steps of providing a urinaryincontinence treatment apparatus as described above, placing at leasttwo laparascopic cannula within a patient's body, and implanting theenergy transforming device in the patient's body by using the at leasttwo laparascopic cannula.

In accordance with a second alternative there is provided a laparoscopicsurgical method of implanting a urinary incontinence treatmentapparatus, comprising the steps of laparascopically placing arestriction device of the apparatus through the abdomen or thorax of apatient, placing at least two laparoscopic trocars within the patient'sbody, using at least one dissecting tool inserted through thelaparoscopic trocar, introducing the restriction device through thetrocar, and placing the restriction device in engagement with theurethra or urine bladder to create a restricted urine passageway.

The method may further comprise implanting an energy transforming deviceof the apparatus, for example subcutaneously, in the abdomen, thorax orcephalic region, or other locations in the patient's body.

The method may further comprise postoperatively adjusting the restrictedurine passageway in a non-invasive procedure.

The present invention also provides a method of treating a human oranimal having chronic urinary incontinence comprising:

(a) Surgically implanting in the human or animal a restriction deviceengaging the human's or animal's urine bladder or urethra, to form arestricted passageway in the urethra or urine bladder.

(b) Surgically implanting in the human or animal an operation device,which can adjust the restricted passageway in response to suppliedenergy. And, (c) in a non-invasive post-operative procedure, from timeto time, supplying energy to the operation device so as to enlarge therestricted passageway to allow urine to readily pass through. In themethod (c) may be practised several times (e.g. 2-10) a day.

The invention is described in more detail in the following withreference to the accompanying drawings, in which

FIGS. 1 to 12 are schematic block diagrams illustrating twelveembodiments, respectively, of the urinary incontinence treatmentapparatus of the invention, in which wireless energy is transmitted fromoutside a patient's body to energy consuming components of the apparatusimplanted in the patient.

FIG. 13 is a schematic block diagram illustrating conceivablecombinations of implanted components for achieving various communicationoptions;

FIG. 14 illustrates an electrical junction element for use in theapparatus of the present invention; and

FIG. 15 illustrates the apparatus in accordance with the inventionimplanted in a patient;

FIG. 16 is a block diagram illustrating remote control components of anembodiment of the invention, in which wireless energy is transmitted bythe use of electromagnetic signals; and

FIG. 17 is a schematic view of exemplary circuitry used for thecomponents of the block diagram of FIG. 16.

Referring to the drawing figures, like reference numerals designateidentical or corresponding elements throughout the several figures.

FIG. 1 schematically shows a most simple embodiment of the urineincontinence disease apparatus of the invention having some partsimplanted in a patient and other parts located outside the patient'sbody. Thus, in FIG. 1 all parts placed to the right of the patient'sskin 2 are implanted and all parts placed to the left of the skin 2 arelocated outside the patient's body.

The apparatus of FIG. 1 comprises an implanted operable restrictiondevice 4, which engages the patient's urethra (or alternatively engagesthe urine bladder) to form a restricted urine passageway in the urethra.The restriction device 4 is capable of performing a reversible function,i.e. to enlarge and reduce the cross-sectional area of the urinepassageway, whereby the restriction device 4 works as an artificialsphincter. An implanted energy transforming device 6 is adapted tosupply energy consuming components of the restriction device 4 withenergy via a power supply line 12. An external energy transmissiondevice 10 includes a wireless remote control for transmitting a wirelesssignal, which is received by a signal receiver incorporated in theimplanted energy transforming device 6. The implanted energytransforming device 6 transforms energy from the signal into electricenergy that is supplied via the power supply line 12.

FIG. 2 shows an embodiment of the invention identical to that of FIG. 1,except that a reversing device in the form of an electric switch 14energy also is implanted in the patient for reversing the restrictiondevice 4. The wireless remote control of the external energytransmission device 10 transmits a wireless signal that carries energyand the implanted energy transforming device 6 transforms the wirelessenergy into a current for operating the switch 14. When the polarity ofthe current is shifted by the energy transforming device 6 the switch 14reverses the function performed by the restriction device 4.

FIG. 3 shows an embodiment of the invention identical to that of FIG. 1,except that an operation device in the form of a motor 15 for operatingthe restriction device 4 also is implanted in the patient. The motor 15is powered with energy from the energy transforming device 6, as theremote control of the external energy transmission device 10 transmits awireless signal to the receiver of the energy transforming device 6.

FIG. 4 shows an embodiment of the invention identical to that of FIG. 1,except that an assembly 16 including a motor/pump unit 18 and a fluidreservoir 20 also is implanted in the patient. In this case therestriction device 4 is hydraulically operated, i.e. hydraulic fluid ispumped by the motor/pump unit 18 from the reservoir 20 through a conduit22 to the restriction device 4 to reduce the cross-sectional area of theurine passageway, and hydraulic fluid is pumped by the motor/pump unit18 back from the restriction device 4 to the reservoir 20 to enlarge thecross-sectional area. The implanted energy transforming device unit 6transforms wireless energy into a current, for example a current, forpowering the motor/pump unit 18 via an electric power supply line 24.

FIG. 5 shows an embodiment of the invention comprising the externalenergy transmission device 10 with its wireless remote control, therestriction device 4, in this case hydraulically operated, and theimplanted energy transforming device 6, and further comprising animplanted hydraulic fluid reservoir 30, an implanted motor/pump unit 32and an implanted reversing device in the form of a hydraulic valveshifting device 34. The motor of the motor/pump unit 32 is an electricmotor. In response to a control signal from the wireless remote controlof the external energy transmission device 10, the implanted energytransforming device 6 powers the motor/pump unit 32 with energy from theenergy carried by the control signal, whereby the motor/pump unit 32distributes hydraulic fluid between the reservoir 30 and the restrictiondevice 4. The remote control of the energy transmission device 10controls the shifting device 34 to shift the hydraulic fluid flowdirection between one direction in which the fluid is pumped by themotor/pump unit 32 from the reservoir 30 to the restriction device 4 toreduce the cross-sectional area of the urine passageway, and anotheropposite direction in which the fluid is pumped by the motor/pump unit32 back from the restriction device 4 to the reservoir 30 to enlarge thecross-sectional area.

FIG. 6 shows an embodiment of the invention identical to that of FIG. 1,except that a control unit 36 controlled by the wireless remote controlof the external energy transmission device 10, an accumulator 38 and acapacitor 40 also are implanted in the patient. The control unit 36stores electric energy received from the energy transforming device 6 inthe accumulator 38, which supplies energy to the restriction device 4.In response to a control signal from the wireless remote control of theenergy transmission device 10, the control unit 6 either releaseselectric energy from the accumulator 38 and transfers the releasedenergy via power lines 42 and 44, or directly transfers electric energyfrom the energy transforming device 6 via a power line 46, the capacitor40, which stabilises the electric current, a power line 48 and the powerline 44, for the operation of the restriction device 4.

In accordance with one alternative, the capacitor 40 in the embodimentof FIG. 6 may be omitted. In accordance with another alternative, theaccumulator 38 in this embodiment may be omitted.

FIG. 7 shows an embodiment of the invention identical to that of FIG. 1,except that a battery 50 for supplying energy for the operation of therestriction device 4 and an electric switch 52 for switching theoperation of the restriction device 4 also are implanted in the patient.The switch 52 is operated by the energy supplied by the energytransforming device 6 to switch from an off mode, in which the battery50 is not in use, to an on mode, in which the battery 50 supplies energyfor the operation of the restriction device 4.

FIG. 8 shows an embodiment of the invention identical to that of FIG. 7,except that a control unit 36 controllable by the wireless remotecontrol of the external energy transmission device 10 also is implantedin the patient. In this case, the switch 52 is operated by the energysupplied by the energy transforming device 6 to switch from an off mode,in which the wireless remote control is prevented from controlling thecontrol unit 36 and the battery is not in use, to a standby mode, inwhich the remote control is permitted to control the control unit 36 torelease electric energy from the battery 50 for the operation of therestriction device 4.

FIG. 9 shows an embodiment of the invention identical to that of FIG. 8,except that an accumulator 38 is substituted for the battery 50 and theimplanted components are interconnected differently. In this case, theaccumulator 38 stores energy from the energy transforming device 6. Inresponse to a control signal from the wireless remote control of theexternal energy transmission device 10, the implanted control unit 36controls the switch 52 to switch from an off mode, in which theaccumulator 38 is not in use, to an on mode, in which the accumulator 38supplies energy for the operation of the restriction device 4.

FIG. 10 shows an embodiment of the invention identical to that of FIG.9, except that a battery 50 also is implanted in the patient and theimplanted components are interconnected differently. In response to acontrol signal from the wireless remote control of the external energytransmission device 10, the implanted control unit 36 controls theaccumulator 38 to deliver energy for operating the switch 52 to switchfrom an off mode, in which the battery 50 is not in use, to an on mode,in which the battery 50 supplies electric energy for the operation ofthe restriction device 4.

Alternatively, the switch 52 may be operated by energy supplied by theaccumulator 38 to switch from an off mode, in which the wireless remotecontrol is prevented from controlling the battery 50 to supply electricenergy and is not in use, to a standby mode, in which the wirelessremote control is permitted to control the battery 50 to supply electricenergy for the operation of the restriction device 4.

FIG. 11 shows an embodiment of the invention identical to that of FIG.7, except that a motor 15, a mechanical reversing device in the form ofa gearbox 54 and a control unit 36 for controlling the gearbox 54 alsoare implanted in the patient. The implanted control unit 36 controls thegearbox 54 to reverse the function performed by the restriction device 4(mechanically operated).

FIG. 12 shows an embodiment of the invention identical to that of FIG.10 except that the implanted components are interconnected differently.Thus, in this case the battery 50 powers the control unit 36 when theaccumulator 38, suitably a capacitor, activates the switch 52 to switchto an on mode. When the switch 52 is in its on mode the control unit 36is permitted to control the battery 50 to supply, or not supply, energyfor the operation of the restriction device 4.

FIG. 13 schematically shows conceivable combinations of implantedcomponents of the apparatus for achieving various communication options.Basically, there are the implanted restriction device 4, control unit 36and motor/pump unit 18, and the external energy transmission device 10including the external wireless remote control. As already describedabove the wireless remote control transmits a control signal which isreceived by the implanted control unit 36, which in turn controls thevarious implanted components of the apparatus.

A sensor 56 may be implanted in the patient for sensing a physicalparameter of the patient, such as the pressure in the urine passageway.The implanted control unit 36, or alternatively the external wirelessremote control of the energy transmission device 10, may control therestriction device 4 in response to signals from the sensor 56. Atransceiver may be combined with the sensor 56 for sending informationon the sensed physical parameter to the external wireless remotecontrol. The wireless remote control may comprise a signal transmitteror transceiver and the implanted control unit 36 may comprise a signalreceiver or transceiver. Alternatively, the wireless remote control maycomprise a signal receiver or transceiver and the implanted control unit36 may comprise a signal transmitter or transceiver. The abovetransceivers, transmitters and receivers may be used for sendinginformation or data related to the restriction device 4 from inside thepatient's body to the outside thereof.

Where the motor/pump unit 18 and battery 50 for powering the motor/pumpunit 18 are implanted, the battery 50 may be equipped with a transceiverfor sending information on the condition of the battery 50.

Those skilled in the art will realise that the above various embodimentsaccording to FIGS. 1-13 could be combined in many different ways. Forexample, the energy operated switch 14 could be incorporated in any ofthe embodiments of FIGS. 3, 6-12, the hydraulic shifting device 34 couldbe incorporated in the embodiment of FIG. 4, and the gearbox 54 could beincorporated in the embodiment of FIG. 3.

FIG. 14 shows an energy transforming device in the form of an electricaljunction element 58 for use in any of the above embodiments according toFIGS. 1-13. The element 58 is a flat p-n junction element comprising ap-type semiconductor layer 60 and an n-type semiconductor layer 62sandwiched together. A light bulb 64 is electrically connected toopposite sides of the element 58 to illustrate how the generated currentis obtained. The output of current from such a p-n junction element 58is correlated to the temperature. See the formula below.I=I0(exp.(qV/kT)−1)where

-   -   I is the external current flow,    -   I0 is the reverse saturation current,    -   q is the fundamental electronic charge of 1.602×10-19 coulombs,    -   V is the applied voltage,    -   k is the Boltzmann constant, and    -   T is the absolute temperature.

Under large negative applied voltage (reverse bias), the exponentialterm becomes negligible compared to 1.0, and I is approximately −I0. I0is strongly dependent on the temperature of the junction and hence onthe intrinsic-carrier concentration. I0 is larger for materials withsmaller bandgaps than for those with larger bandgaps. The rectifieraction of the diode—that is, its restriction of current flow to only onedirection—is in this particular embodiment the key to the operation ofthe p-n junction element 58.

An alternative way to design a p-n junction element is to deposit a thinlayer of semiconductor onto a supporting material which does not absorbthe kind of energy utilised in the respective embodiments. For use withwirelessly transmitted energy in terms of light waves, glass could be asuitable material. Various materials may be used in the semiconductorlayers such as but not limited to cadmium telluride,copper-indium-diselenide and silicon. It is also possible to use amultilayer structure with several layers of p and n-type materials toimprove efficiency.

The electric energy generated by the p-n junction element 58 could be ofthe same type as generated by solar cells, in which the negative andpositive fields create a direct current. Alternatively, the negative andpositive semiconductor layers may change polarity following thetransmitted waves, thereby generating an alternating current.

The p-n junction element 58 is designed to make it suited forimplantation. Thus, all the external surfaces of the element 58 incontact with the human body are made of a biocompatible material. Thep-n junction semiconductors are designed to operate optimally at a bodytemperature of 37° C. because the current output, which should be morethan 1 μA, is significantly depending on temperature as shown above.Since both the skin and subcutis absorb energy, the relation between thesensitivity or working area of the element 58 and the intensity orstrength of the wireless energy transmission is considered. The p-njunction element 58 preferably is designed flat and small.Alternatively, if the element 58 is made in larger sizes it should beflexible, in order to adapt to the patient's body movements. The volumeof the element 58 should be kept less than 2000 cm³.

FIG. 15 generally illustrates how any of the above-described embodimentsof the urine incontinence disease treatment apparatus of the inventionmay be implanted in a patient. Thus, a restriction device 4 implanted ina patient engages the urethra 66 to form an artificial sphincter aroundthe urine passageway in the urethra 66. An implanted operation device68, such as an electric motor or a motor/pump assembly, operates therestriction device 4 through a transmission member 70, such as amechanical transmission cord or a fluid tube. An energy transformingdevice in the form of an element 6 having a positive region and anegative region, as described above in more detail, is placed underneaththe skin of the patient.

Wireless energy carried by a signal transmitted by a wireless remotecontrol of an external energy transmission device 10 at least partlypenetrates the patient's skin and hits the element 6. The energy thushitting the element 6 is transformed into energy of a different formthat is suited for powering the operation device 68. For example, wherethe operation device 68 is an electric motor the element 6 comprises anelectric p-n junction element that transforms the wireless energy intoan electric current for powering the electric motor. Where the operationdevice 68 comprises a pump, the element 6 may transform the wirelessenergy into kinetic energy for powering the pump.

The transformed energy may be utilised for directly operating therestriction device 4 or, where the restriction device 4 is electricallyoperated, for storage in a capacitor and/or an accumulator for later orparallel use. Preferably (but not necessarily) the element 6 iscontrolled by a microprocessor. The wireless remote control of theexternal energy transmission device 10 is used to control theutilisation of the transmitted energy and any function or commandto/from the implanted restriction device 4.

FIG. 16 shows the basic parts of a wireless remote control of theapparatus of the invention including an electric motor 128 for operatinga restriction member, for example of the type illustrated in FIG. 15. Inthis case, the remote control is based on the transmission ofelectromagnetic wave signals, often of high frequencies in the order of100 kHz-1 gHz, through the skin 130 of the patient. In FIG. 15, allparts placed to the left of the skin 130 are located outside thepatient's body and all parts placed to the right of the skin 130 areimplanted. Any suitable remote control system may be used.

An external signal transmitting antenna 132 is to be positioned close toa signal receiving antenna 134 implanted close to the skin 130. As analternative, the receiving antenna 134 may be placed for example insidethe abdomen of the patient. The receiving antenna 134 comprises a coil,approximately 1-100 mm, preferably 25 mm in diameter, wound with a verythin wire and tuned with a capacitor to a specific high frequency. Asmall coil is chosen if it is to be implanted under the skin of thepatient and a large coil is chosen if it is to be implanted in theabdomen of the patient. The transmitting antenna 132 comprises a coilhaving about the same size as the coil of the receiving antenna 134 butwound with a thick wire that can handle the larger currents that isnecessary. The coil of the transmitting antenna 132 is tuned to the samespecific high frequency as the coil of the receiving antenna 134.

An external control unit 136 comprises a microprocessor, a highfrequency electromagnetic wave signal generator and a power amplifier.The microprocessor of the control unit 136 is adapted to switch thegenerator on/off and to modulate signals generated by the generator tosend digital information via the power amplifier and the antennas 132,134 to an implanted control unit 138. To avoid that accidental randomhigh frequency fields trigger control commands, digital signal codes areused. A conventional keypad placed on the external control unit 136 isconnected to the microprocessor thereof. The keypad is used to order themicroprocessor to send digital signals to either contract or enlarge therestriction device. The microprocessor starts a command by applying ahigh frequency signal on the antenna 132. After a short time, when thesignal has energised the implanted parts of the control system, commandsare sent to contract or enlarge the restriction device in predefinedsteps. The commands are sent as digital packets in the form illustratedbelow.

Start pattern, Command, Count, Checksum, 8 bits 8 bits 8 bits 8 bits

The commands are sent continuously during a rather long time period(e.g. about 30 seconds or more). When a new contract or enlarge step isdesired the Count byte is increased by one to allow the implantedcontrol unit 138 to decode and understand that another step is demandedby the external control unit 136. If any part of the digital packet iserroneous, its content is simply ignored.

Through a line 140, an implanted energiser unit 126 draws energy fromthe high frequency electromagnetic wave signals received by thereceiving antenna 134. The energiser unit 126 stores the energy in anenergy storage device, such as a large capacitor, powers the controlunit 138 and powers the electric motor 128 via a line 142.

The control unit 138 comprises a demodulator and a microprocessor. Thedemodulator demodulates digital signals sent from the external controlunit 136. The microprocessor of the control unit 138 receives thedigital packet, decodes it and, provided that the power supply of theenergiser unit 126 has sufficient energy stored, sends a signal via asignal line 144 to the motor 128 to either contract or enlarge therestriction device depending on the received command code.

Alternatively, the energy stored in the energy storage device of theenergiser unit may only be used for powering a switch, and the energyfor powering the motor 128 may be obtained from another implanted energysource of relatively high capacity, for example a battery. In this casethe switch is adapted to connect said battery to the control unit 138 inan on mode when said switch is powered by the energy storage device andto keep the battery disconnected from the control unit in a standby modewhen the switch is not powered.

With reference to FIG. 17, the remote control schematically describedabove will now be described in accordance with a more detailedembodiment. The external control unit 136 comprises a microprocessor146, a signal generator 148 and a power amplifier 150 connected thereto.The microprocessor 146 is adapted to switch the signal generator 148on/off and to modulate signals generated by the signal generator 148with digital commands that are sent to implanted components of theapparatus. The power amplifier 150 amplifies the signals and sends themto the external signal transmitting antenna 132. The antenna 132 isconnected in parallel with a capacitor 152 to form a resonant circuittuned to the frequency generated by the signal generator 148.

The implanted signal receiving antenna coil 134 forms together with acapacitor 154 a resonant circuit that is tuned to the same frequency asthe transmitting antenna 132. The signal receiving antenna coil 134induces a current from the received high frequency electromagnetic wavesand a rectifying diode 160 rectifies the induced current, which chargesa storage capacitor 158. A coil 156 connected between the antenna coil134 and the diode 160 prevents the capacitor 158 and the diode 160 fromloading the circuit of the signal receiving antenna 134 at higherfrequencies. Thus, the coil 156 makes it possible to charge thecapacitor 158 and to transmit digital information using amplitudemodulation.

A capacitor 162 and a resistor 164 connected in parallel and a diode 166forms a detector used to detect amplitude modulated digital information.A filter circuit is formed by a resistor 168 connected in series with aresistor 170 connected in series with a capacitor 172 connected inseries with the resistor 168 via ground, and a capacitor 174, oneterminal of which is connected between the resistors 168, 170 and theother terminal of which is connected between the diode 166 and thecircuit formed by the capacitor 162 and resistor 164. The filter circuitis used to filter out undesired low and high frequencies. The detectedand filtered signals are fed to an implanted microprocessor 176 thatdecodes the digital information and controls the motor 128 via anH-bridge 178 comprising transistors 180, 182, 184 and 186. The motor 128can be driven in two opposite directions by the H-bridge 178.

The microprocessor 176 also monitors the amount of stored energy in thestorage capacitor 158. Before sending signals to activate the motor 128,the microprocessor 176 checks whether the energy stored in the storagecapacitor 158 is enough. If the stored energy is not enough to performthe requested operation, the microprocessor 176 waits for the receivedsignals to charge the storage capacitor 158 before activating the motor128.

1. A urinary incontinence disease treatment apparatus for treatment of apatient, who suffers from urinary incontinence, the apparatus arestriction device implantable in the patient for engaging the urethraor urine bladder to form a restricted urine passageway therein, therestriction device being operable to change the restriction of the urinepassageway, an energy transmission device for wireless transmission ofenergy of a first form from outside the patient's body to inside thepatient's body, and an energy transforming device implantable in thepatient for transforming the energy of the first form wirelesslytransmitted by the energy transmission device into energy of a secondform different than the energy of the first is form, the restrictiondevice being operable in response to the energy of the second form tochange the restriction of the urine passageway, when the restrictiondevice is implanted, characterised in that the energy transformingdevice comprises at least one element having a positive region and anegative region, that the element is capable of creating an energy fieldbetween the positive and negative regions when exposed to the energy ofthe first form transmitted by the energy transmission device, and thatthe energy field produces the energy of the second form; and wherein theenergy of the second form used for operating the restriction device iswirelessly transmitted by the energy transforming device.
 2. A urinaryincontinence disease treatment apparatus for treatment of a patient, whosuffers from urinary incontinence, the apparatus a restriction deviceimplantable in the patient for engaging the urethra or urine bladder toform a restricted urine passageway therein, the restriction device beingoperable to change the restriction of the urine passageway, an energytransmission device for wireless transmission of energy of a first formfrom outside the patient's body to inside the patient's body, and anenergy transforming device implantable in the patient for transformingthe energy of the first form wirelessly transmitted by the energytransmission device into energy of a second form different than theenergy of the first is form, the restriction device being operable inresponse to the energy of the second form to change the restriction ofthe urine passageway, when the restriction device is implanted,characterized in that the energy transforming device comprises at leastone element having a positive region and a negative region, that theelement is capable of creating an energy field between the positive andnegative regions when exposed to the energy of the first formtransmitted by the energy transmission device, and that the energy fieldproduces the energy of the second form, and wherein the energytransforming device comprises at least one semiconductor type ofcomponent.
 3. An apparatus according to claim 2, wherein the energytransforming device comprises a circuitry of semiconductor components.4. An apparatus according to claim 3, wherein the semiconductorcomponent comprises at least one element having a positive region and anegative region, the element is capable of creating an energy fieldbetween the positive and negative regions when exposed to the energy ofthe first form transmitted by the energy transmission device, and theenergy field produces the energy of the second form.
 5. An apparatusaccording to claim 2, wherein the semiconductor component comprises atransistor or microchip or similar electronic components excludingrectifying diodes.
 6. An apparatus according to claim 2, wherein theenergy transforming device comprises a capacitor and the energy of thesecond form comprises electric energy.
 7. An apparatus according toclaim 2, further comprising implantable electrical components includingat least one voltage level guard.
 8. A urinary incontinence diseasetreatment apparatus for treatment of a patient, who suffers from urinaryincontinence, the apparatus a restriction device implantable in thepatient for engaging the urethra or urine bladder to form a restrictedurine passageway therein, the restriction device being operable tochange the restriction of the urine passageway, an energy transmissiondevice for wireless transmission of energy of a first form from outsidethe patient's body to inside the patient's body, and an energytransforming device implantable in the patient for transforming theenergy of the first form wirelessly transmitted by the energytransmission device into energy of a second form different than theenergy of the first is form, the restriction device being operable inresponse to the energy of the second form to change the restriction ofthe urine passageway, when the restriction device is implanted,characterised in that the energy transforming device comprises at leastone element having a positive region and a negative region, that theelement is capable of creating an energy field between the positive andnegative regions when exposed to the energy of the first formtransmitted by the energy transmission device, and that the energy fieldproduces the energy of the second form; and wherein the energytransmission device functions differently from the energy transformingdevice.
 9. An apparatus according to claim 8, wherein the energytransmission device transmits energy by at least one wireless signal.10. An apparatus according to claim 9, wherein the signal containsradiant energy.
 11. An apparatus according to claim 9, wherein thesignal comprises a wave signal.
 12. An apparatus according to claim 11,wherein the wave signal comprises an electromagnetic wave signalincluding one of an infrared light signal, a visible light signal, anultraviolet light signal, a laser signal, a micro wave signal, a radiowave signal, an x-ray radiation signal, and a gammaradiation signal. 13.An apparatus according to claim 11, wherein the wave signal comprises asound or ultrasound wave signal.
 14. A urinary incontinence diseasetreatment apparatus for treatment of a patient, who suffers from urinaryincontinence, the apparatus a restriction device implantable in thepatient for engaging the urethra or urine bladder to form a restrictedurine passageway therein, the restriction device being operable tochange the restriction of the urine passageway, an energy transmissiondevice for wireless transmission of energy of a first form from outsidethe patient's body to inside the patient's body, and an energytransforming device implantable in the patient for transforming theenergy of the first form wirelessly transmitted by the energytransmission device into energy of a second form different than theenergy of the first is form, the restriction device being operable inresponse to the energy of the second form to change the restriction ofthe urine passageway, when the restriction device is implanted,characterised in that the energy transforming device comprises at leastone element having a positive region and a negative region, that theelement is capable of creating an energy field between the positive andnegative regions when exposed to the energy of the first formtransmitted by the energy transmission device, and that the energy fieldproduces the energy of the second form; and wherein the apparatusfurther comprises an implantable pulse generator for generatingelectrical pulses from the energy of the second form produced by theenergy field.
 15. An apparatus according to claim 14, wherein the energytransforming device comprises a capacitor and the energy of the secondform comprises electric energy.
 16. An apparatus according to claim 15,wherein the capacitor is adapted to produce electric pulses from thetransformed electric energy.
 17. An apparatus according to claim 16,wherein the capacitor is adapted to produce the pulses of the electricenergy, as the energy transforming device transforms the energy of thefirst form transmitted by the energy transmission device into theelectric energy of the second form.
 18. An apparatus according to claim14, further comprising implantable electrical components including atleast one voltage level guard.
 19. A urinary incontinence diseasetreatment apparatus for treatment of a patient, who suffers from urinaryincontinence, the apparatus comprising a restriction device implantablein the patient for engaging the urethra or urine bladder to form arestricted urine passageway therein, the restriction device beingoperable to change the restriction of the urine passageway, an energytransmission device for wireless transmission of energy of a first formfrom outside the patient's body to inside the patient's body, and anenergy transforming device implantable in the patient for transformingthe energy of the first form wirelessly transmitted by the energytransmission device into energy of a second form different than theenergy of the first is form, the restriction device being operable inresponse to the energy of the second form to change the restriction ofthe urine passageway, when the restriction device is implanted,characterised in that the energy transforming device comprises at leastone element having a positive region and a negative region, that theelement is capable of creating an energy field between the positive andnegative regions when exposed to the energy of the first formtransmitted by the energy transmission device, and that the energy fieldproduces the energy of the second form, and wherein the energytransforming device forms a flat and thin sheet, and has a volume ofless than 2000 cm³.
 20. An apparatus according to claim 19, wherein theenergy transforming device comprises a capacitor and the energy of thesecond form comprises electric energy.
 21. An apparatus according toclaim 19, wherein the energy transforming device comprises a circuitryof semiconductor components.
 22. An apparatus according to claim 19,wherein the semiconductor component comprises a transistor or microchipor similar electronic components excluding rectifying diodes.
 23. Aurinary incontinence disease treatment apparatus for treatment of apatient, who suffers from urinary incontinence, the apparatus comprisinga restriction device implantable in the patient for engaging the urethraor urine bladder to form a restricted urine passageway therein, therestriction device being operable to change the restriction of the urinepassageway, an energy transmission device for wireless transmission ofenergy of a first form from outside the patient's body to inside thepatient's body, and an energy transforming device implantable in thepatient for transforming the energy of the first form wirelesslytransmitted by the energy transmission device into energy of a secondform different than the energy of the first is form, the restrictiondevice being operable in response to the energy of the second form tochange the restriction of the urine passageway, when the restrictiondevice is implanted, characterised in that the energy transformingdevice comprises at least one element having a positive region and anegative region, that the element is capable of creating an energy fieldbetween the positive and negative regions when exposed to the energy ofthe first form transmitted by the energy transmission device, and thatthe energy field produces the energy of the second form, wherein theenergy transforming device is adapted to transform the energy of thefirst form directly or indirectly into the energy of the second form,and wherein the wireless energy of the first form comprises sound wavesand the energy of the second form comprises electric energy.
 24. Anapparatus according to claim 23, wherein the energy transforming devicecomprises a capacitor and the energy of the second form compriseselectric energy.
 25. An apparatus according to claim 23 furthercomprising implantable electrical components including at least onevoltage level guard.
 26. An apparatus according to claim 23, furthercomprising an implantable operation device for operating the restrictiondevice, wherein the energy transforming device powers the operationdevice with the energy of the second form.
 27. An apparatus according toclaim 23, wherein the restriction device is non-inflatable.
 28. Aurinary incontinence disease treatment apparatus for treatment of apatient, who suffers from urinary incontinence, the apparatus arestriction device implantable in the patient for engaging the urethraor urine bladder to form a restricted urine passageway therein, therestriction device being operable to change the restriction of the urinepassageway, an energy transmission device for wireless transmission ofenergy of a first form from outside the patient's body to inside thepatient's body, and an energy transforming device implantable in thepatient for transforming the energy of the first form wirelesslytransmitted by the energy transmission device into energy of a secondform different than the energy of the first is form, the restrictiondevice being operable in response to the energy of the second form tochange the restriction of the urine passageway, when the restrictiondevice is implanted, characterised in that the energy transformingdevice comprises at least one element having a positive region and anegative region, that the element is capable of creating an energy fieldbetween the positive and negative regions when exposed to the energy ofthe first form transmitted by the energy transmission device, and thatthe energy field produces the energy of the second form; and wherein theapparatus further comprises an activatable source of energy implantablein the patient, wherein the source of energy is activated by wirelessenergy transmitted by the energy transmission device, to supply energywhich is used in connection with the operation of the restrictiondevice.
 29. A urinary incontinence disease treatment apparatus fortreatment of a patient, who suffers from urinary incontinence, theapparatus a restriction device implantable in the patient for engagingthe urethra or urine bladder to form a restricted urine passagewaytherein, the restriction device being operable to change the restrictionof the urine passageway, an energy transmission device for wirelesstransmission of energy of a first form from outside the patient's bodyto inside the patient's body, and an energy transforming deviceimplantable in the patient for transforming the energy of the first formwirelessly transmitted by the energy transmission device into energy ofa second form different than the energy of the first is form, therestriction device being operable in response to the energy of thesecond form to change the restriction of the urine passageway, when therestriction device is implanted, characterised in that the energytransforming device comprises at least one element having a positiveregion and a negative20 region, that the element is capable of creatingan energy field between the positive and negative regions when exposedto the energy of the first form transmitted by the energy transmissiondevice, and that the energy field produces the energy of the secondform; and wherein the energy transmitted by the energy transmissiondevice comprises polarised energy.
 30. A urinary incontinence diseasetreatment apparatus for treatment of a patient, who suffers from urinaryincontinence, the apparatus comprising a restriction device implantablein the patient for engaging the urethra or urine bladder to form arestricted urine passageway therein, the restriction device beingoperable to change the restriction of the urine passageway, an energytransmission device for wireless transmission of energy of a first formfrom outside the patient's body to inside the patient's body, and anenergy transforming device implantable in the patient for transformingthe energy of the first form wirelessly transmitted by the energytransmission device into energy of a second form different than theenergy of the first is form, the restriction device being operable inresponse to the energy of the second form to change the restriction ofthe urine passageway, when the restriction device is implanted,characterised in that the energy transforming device comprises at leastone element having a positive region and a negative region, that theelement is capable of creating an energy field between the positive andnegative regions when exposed to the energy of the first formtransmitted by the energy transmission device, and that the energy fieldproduces the energy of the second form; and wherein the apparatusfurther comprises implantable electrical components including at leastone voltage level guard.
 31. An apparatus according to claim 30, whereinthe element comprises an electrical junction element, and the electricaljunction element is capable of inducing an electric field between thepositive and negative regions when exposed to the energy of the firstform transmitted by the energy transmission device, whereby the energyof the second form comprises electric energy.
 32. An apparatus accordingto claim 31, wherein the restriction device is electrically operated,and the positive and negative regions of the electrical junction elementsupply electric energy for the operation of the restriction device. 33.An apparatus according to claim 32, further comprising electricconductors connected to the positive and negative regions of theelectrical junction element, whereby the electrical junction element iscapable of supplying an electric current via the conductors.
 34. Anapparatus according to claim 31, wherein the energy transforming devicecomprises a capacitor and the energy of the second form compriseselectric energy.
 35. An apparatus according to claim 34, wherein thecapacitor is adapted to produce electric pulses from the transformedelectric energy.
 36. An apparatus according to claim 35, wherein thecapacitor is adapted to produce the pulses of the electric energy, asthe energy transforming device transforms the energy of the first formtransmitted by the energy transmission device into the electric energyof the second form.
 37. An apparatus according to claim 35, wherein thecontrol device is adapted to control the energy transforming device toproduce the energy of the second form in a train of energy pulses fordirect use in connection with the operation of the restriction device.38. An apparatus according to claim 34, wherein the capacitor has acapacity less than 0, 1 μF.
 39. An apparatus according to claims 30, 28or 29, wherein the energy transforming device is adapted to transformthe energy of the first form directly or indirectly into the energy ofthe second form, and wherein the apparatus further comprises animplantable motor or pump for operating the restriction device, and themotor or pump is powered by the energy of the second form.
 40. Anapparatus according to claim 39, wherein the energy transforming deviceis adapted to directly power the motor or pump by the transformedenergy, as the energy of the second form is being transformed from theenergy of the first form.
 41. An apparatus according to claims 30, 28 or29, further comprising an implantable stabiliser for stabilising theenergy of the second form.
 42. An apparatus according to claim 41,wherein the energy of the second form comprises electric current and thestabilizer comprises at least one capacitor.
 43. An apparatus accordingto claim 30, further comprising an implantable capacitor or accumulator,wherein the charge or discharge of the capacitor or accumulator iscontrolled by use of the voltage level guard.
 44. An apparatus accordingto claim 30, wherein the energy transmission device is adapted totransmit wireless energy for direct use in connection with the operationof the restriction device, as the wireless energy is being transmitted.45. An apparatus according to claim 44, wherein the energy transmissiondevice is adapted to transmit wireless energy in the form of a magneticfield or electromagnetic waves for direct power of a motor or pump foroperating the restriction device.
 46. An apparatus according to claim30, wherein the energy transmission device is adapted to transmitwireless energy for direct use in connection with the operation of therestriction device, as the wireless energy is being transmitted andwherein the apparatus further comprises an implantable motor or pump foroperating the restriction device, and the energy transmission device isadapted to directly power the motor or pump with wireless energy.
 47. Anapparatus according to claim 46, wherein the pump is not a plunger typeof pump.
 48. An apparatus according to claims 30, 28 or 29, furthercomprising an implantable motor for direct or intermittent operation ofthe restriction device, wherein the energy transforming device powersthe motor with the energy of the second form.
 49. An apparatus accordingto claim 48, wherein the restriction device is operable to perform areversible function and the motor is capable of reversing said function.50. An apparatus according to claim 48, further comprising animplantable gearing connected to the motor.
 51. An apparatus accordingto claims 30, 28 or 29, wherein the restriction device comprises ahydraulic restriction device, and further comprising an implantable pumpfor operating the hydraulic restriction device, the energy transformingdevice supplying the energy of the second form for driving the pump. 52.An apparatus according to claim 30, further comprising an implantableoperation device for operating the restriction device, wherein theenergy transforming device powers the operation device with the energyof the second form.
 53. An apparatus according to claim 52, wherein theoperation device comprises hydraulic means and at least one valve forcontrolling a fluid flow in the hydraulic means.
 54. An apparatusaccording to claim 53, further comprising a wireless remote control forcontrolling the valve.
 55. An apparatus according to claim 30, furthercomprising a control device for controlling the operation device.
 56. Anapparatus according to claim 55, wherein the operation device comprisesa motor.
 57. An apparatus according to claim 56, wherein the motorcomprises a linear motor.
 58. An apparatus according to claim 56,wherein the motor comprises an electric motor having electricallyconductive parts made of plastic.
 59. An apparatus according to claim55, wherein the motor comprises a rotary motor and the control devicecontrols the rotary motor to rotate a desired number of revolutions. 60.An apparatus according to claim 55, wherein the motor comprises ahydraulic or pneumatic fluid motor, and the control device controls thefluid motor.
 61. An apparatus according to claim 55, wherein therestriction device comprises hydraulic means and the operation device isadapted to conduct a hydraulic fluid in the hydraulic means.
 62. Anapparatus according to claim 61, wherein the operation device comprisesa fluid conduit connected to the hydraulic means of the restrictiondevice, and a reservoir for fluid, the reservoir forming part of theconduit.
 63. An apparatus according to claim 62, wherein the hydraulicmeans and conduit are devoid of any non-return valve.
 64. An apparatusaccording to claim 63, wherein the reservoir forms a fluid chamber witha variable volume, and the operation device is adapted to distributefluid from the chamber to the hydraulic means of the restriction deviceby reduction of the volume of the chamber and to withdraw fluid from thehydraulic means to the chamber by expansion of the volume of thechamber.
 65. An apparatus according to claim 64, wherein the operationdevice comprises an implantable motor used for reducing and expandingthe volume of the chamber.
 66. An apparatus according to claim 61,wherein the operation device comprises an implantable pump for pumpingthe hydraulic fluid in the hydraulic means of the restriction device.67. An apparatus according to claim 55, wherein the control deviceshifts polarity of the energy of the second form to reverse theoperation device.
 68. An apparatus according to claim 55, wherein thecontrol device controls the reversing device to reverse the functionperformed by the restriction device.
 69. An apparatus according toclaims 30, 28 or 29, further comprising an energy storage deviceimplantable in the patient for storing the energy of the second form andfor supplying energy in connection with the operation of the restrictiondevice.
 70. An apparatus according to claim 69, wherein the energystorage device comprises an accumulator.
 71. An apparatus according toclaim 69, wherein the energy of the second form comprises electricenergy and the energy storage device comprises an electric accumulator.72. An apparatus according to claim 71, wherein the electric accumulatorcomprises at least one capacitor or at least one rechargeable battery,or a combination of at least one capacitor and at least one rechargeablebattery.
 73. An apparatus according to claims 30, 28 or 29, furthercomprising a switch implantable in the patient for directly orindirectly switching the operation of the restriction device.
 74. Anapparatus according to claim 73, further comprising a source of energyimplantable in the patient, wherein the switch is operated by the energyof the second form supplied by the energy storage device to switch froman off mode, in which the source of energy is not in use, to an on mode,by which the source of energy supplies energy for the operation of therestriction device.
 75. An apparatus according to claim 73, furthercomprising a source of energy implantable in the patient, and a remotecontrol for controlling the supply of energy of the source of energy,wherein the switch is operated by the energy of the second form suppliedby the energy storage device to switch from an off mode, in which theremote control is prevented from controlling the source of energy andthe source of energy is not in use, to a standby mode, in which theremote control is permitted to control the source of energy to supplyenergy for the operation of the restriction device.
 76. An apparatusaccording to claim 73, further comprising a source of energy implantablein the patient for supplying energy for the operation of the restrictiondevice, wherein the switch is operated by the energy of the second formsupplied by the energy transforming device to switch from an off mode,in which the source of energy is not in use, to an on mode, in which thesource of energy supplies energy for the operation of the restrictiondevice.
 77. An apparatus according to claim 73, further comprising asource of energy implantable in the patient for supplying energy for theoperation of the restriction device, and a remote control forcontrolling the supply of energy of the implantable source of energy,wherein the switch is operated by the energy of the second form suppliedby the energy transforming device to switch from an off mode, in whichthe remote control is prevented from controlling the source of energyand the source of energy is not in use, to a standby mode, in which theremote control is permitted to control the source of energy to supplyenergy for the operation of the restriction device.
 78. An apparatusaccording to claim 73, further comprising a source of energy implantablein the patient for supplying energy for the operation of the restrictiondevice, wherein the switch is operated by the energy of the first formsupplied by the energy transmission device to switch from an off mode,in which the source of energy is not in use, to an on mode, in which thesource of energy supplies energy for the operation of the restrictiondevice.
 79. An apparatus according to claim 73, further comprising asource of energy implantable in the patient for supplying energy for theoperation of the restriction device, and a remote control forcontrolling the supply of energy of the implantable source of energy,wherein the switch is operated by the energy of the first form suppliedby the energy transmission device to switch from an off mode, in whichthe remote control is prevented from controlling the source of energyand the source of energy is not in use, to a standby mode, in which theremote control is permitted to control the source of energy to supplyenergy for the operation of the restriction device.
 80. An apparatusaccording to claim 30, wherein the restriction device is operable toperform a reversible function.
 81. An apparatus according to claim 80,further comprising a reversing device implantable in the patient forreversing the function performed by the restriction device.
 82. Anapparatus according to claim 81, wherein the reversing device compriseshydraulic means including a valve for shifting the flow direction of afluid flow in the hydraulic means.
 83. An apparatus according to claim81, wherein the reversing device comprises a mechanical reversingdevice.
 84. An apparatus according to claim 83, wherein the reversingdevice comprises a gearbox.
 85. An apparatus according to claim 81,wherein the reversing device comprises a switch.
 86. An apparatusaccording to claim 85, wherein the switch is operable by the energy ofthe second form.
 87. An apparatus according to claim 86, wherein thecontrol device controls the operation of the switch by shifting polarityof the energy of the second form.
 88. An apparatus according to claim86, wherein the switch comprises an electric switch and the energy ofthe second form comprises electric energy.
 89. An apparatus according toclaim 85 wherein the reversing device comprises a mechanical reversingdevice.
 90. An apparatus according to claim 89, wherein the reversingdevice comprises a gearbox.
 91. An apparatus according to claim 30,wherein the energy transmission device transmits energy by at least onewireless signal.
 92. An apparatus according to claim 91, wherein thesignal contains radiant energy.
 93. An apparatus according to claim 91,wherein the signal comprises a wave signal.
 94. An apparatus accordingto claim 93, wherein the wave signal comprises an electromagnetic wavesignal including one of an infrared light signal, a visible lightsignal, an ultraviolet light signal, a laser signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal, and agammaradiation signal.
 95. An apparatus according to claim 93, whereinthe wave signal comprises a sound or ultrasound wave signal.
 96. Anapparatus according to claim 91, wherein the signal comprises a digitalor analog signal, or a combination of a digital and analog signal. 97.An apparatus according to claim 30, wherein the energy of the first formtransmitted by the energy transmission device comprises an electric, anelectromagnetic or a magnetic field, or a combination thereof.
 98. Anapparatus according to claim 97, wherein the electric, electromagneticor magnetic field, or the combination thereof is transmitted in pulsesor digital pulses, or a combination of pulses and digital pulses by theenergy transmission device.
 99. An apparatus according to claims 30, 28or 29, wherein the energy of a first form transmitted by the energytransmission device comprises an electric, an electromagnetic or amagnetic field, or a combination thereof.
 100. An apparatus according toclaim 99, wherein the electric, electromagnetic or magnetic field, orthe combination thereof is transmitted in waves or analog pulses or acombination thereof by the energy transmission device.
 101. An apparatusaccording to claim 30, 28 or 29, wherein the energy transforming devicetransforms the energy of the first form into a direct current orpulsating direct current, or a combination of a direct current andpulsating direct current.
 102. An apparatus according to claim 30, 28 or29, wherein the energy transforming device transforms the energy of thefirst form into an alternating current or a combination of a direct andalternating current.
 103. An apparatus according to claim 30, furthercomprising at least one implantable sensor for sensing at least onephysical parameter of the patient.
 104. An apparatus according to claim103, wherein the sensor comprises a pressure sensor for directly orindirectly sensing as the physical parameter the pressure in the urinepassageway or the pressure against the urethra or the lower part of theurine bladder.
 105. An apparatus according to claim 103, furthercomprising a control device for controlling the restriction device inresponse to signals from the sensor.
 106. An apparatus according toclaim 105, wherein the control device comprises an internal control unitimplantable in the patient for controlling the restriction device inresponse to signals from the sensor.
 107. An apparatus according toclaim 106, wherein the internal control unit directly controls therestriction device in response to signals from the sensor.
 108. Anapparatus according to claim 105, wherein the control device comprisesan external control unit outside the patient's body for controlling therestriction device in response to signals from the sensor.
 109. Anapparatus according to claim 108, wherein the external control unitstores information on the physical parameter sensed by the sensor and ismanually operated to control the restriction device based on the storedinformation.
 110. An apparatus according to claim 103, furthercomprising at least one implantable sender for sending information onthe physical parameter sensed by the sensor.
 111. An apparatus accordingto claim 30, further comprising a wireless remote control fortransmitting at least one wireless control signal for controlling therestriction device.
 112. An apparatus according to claim 111, whereinthe control signal comprises a frequency, amplitude or frequency oramplitude modulated signal.
 113. An apparatus according to claim 111,wherein the wireless remote control comprises at least one externalsignal transmitter or transceiver and at least one internal signalreceiver or transceiver implantable in the patient.
 114. An apparatusaccording to claim 111, wherein the wireless remote control comprises atleast one external signal receiver or transceiver and at least oneinternal signal transmitter or transceiver implantable in the patient.115. An apparatus according to claim 111, wherein the remote control iscapable of sending information related to the restriction device frominside the patients body to the outside thereof.
 116. An apparatusaccording to claim 115, wherein the remote control controls therestriction device in response to the information.
 117. An apparatusaccording to claim 111, wherein the remote control comprises a controlsignal transmitter for transmitting the wireless control signal, and theenergy transmission device comprises the control signal transmitter,whereby energy is transmitted by the control signal.
 118. An apparatusaccording to claim 111, wherein the energy transmission device transmitsenergy by at least one signal separate from the control signal.
 119. Anapparatus according to claim 111, wherein the remote control transmits acarrier signal for carrying the control signal.
 120. An apparatusaccording to claim 111, wherein the energy transmission device transmitsenergy by at least one signal, which is used as a carrier signal for thecontrol signal transmitted by the remote control.
 121. An apparatusaccording to claim 111, wherein the remote control comprises animplantable control unit for controlling the restriction device.
 122. Anapparatus according to claim 121, wherein the control unit comprises amicroprocessor.
 123. An apparatus according to claim 111, wherein theremote control is capable of obtaining information on the condition ofthe implantable restriction device and to control the restriction devicein response to the information.
 124. An apparatus according to claim111, wherein the control signal comprises a wave signal comprising oneof a sound wave signal, an ultrasound wave signal, an electromagneticwave signal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a micro wave signal, a radiowave signal, an x-ray radiation signal and a gamma radiation signal.125. An apparatus according to claim 111, wherein the control signalcomprises an electric or magnetic field, or a combined electric andmagnetic field.
 126. An apparatus according to claim 111, wherein thecontrol signal comprises an analog or a digital signal, or a combinationof an analog and digital signal.
 127. An apparatus according to claim30, further comprising an implantable control unit for controlling therestriction device.
 128. An apparatus according to, claim 30, 28 or 29,wherein the restriction device is embedded in a soft or gel-likematerial.
 129. An apparatus according to claim 127, wherein the controlunit is programmable for controlling the restriction device inaccordance with a program.
 130. An apparatus according to claim 127,wherein the control unit controls the restriction device over time inaccordance with an activity schedule program.
 131. An apparatusaccording to claim 127, further comprising an external wireless remotecontrol for programming the implantable control unit.
 132. An apparatusaccording to claim 131, wherein the control unit controls therestriction device over time in accordance with an activity scheduleprogram.
 133. An apparatus according to claims 30, 28 or 29, furthercomprising an external data communicator and an implantable internaldata communicator communicating with the external data communicator,wherein the internal communicator feeds data related to the restrictiondevice back to the external data communicator or the 10 external datacommunicator feeds data to the internal data communicator.
 134. Anapparatus according to claim 30, wherein the restriction device isadapted to control the restriction of the urine passageway whenimplanted.
 135. An apparatus according to claim 30, 28 or 29, whereinthe restriction device is non-inflatable.
 136. An apparatus according toclaim 30, wherein one of the energy of the first form and the energy ofthe second form comprises magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photoenergy,nuclear energy or thermal energy.
 137. An apparatus according to claim30, wherein one of the energy of the first form and the energy of thesecond form is non-magnetic, non-kinetic, non-chemical, non-sonic,non-nuclear or non-thermal.
 138. An apparatus according to claims 30, 28or 29, wherein the restriction device is embedded in a silicone materialhaving hardness less than 10 Shore.
 139. An apparatus according toclaims 30, 28 or 29 wherein the energy transmission device functionssimilar to the energy transforming device.
 140. An apparatus accordingto claims 30, 28 or 29 wherein the energy transforming device isdesigned to be implanted subcutaneously or in the abdomen, thorax orcephalic region of the patient.
 141. An apparatus according to claims30, 28 or 29, wherein the energy transforming device is designed to beimplanted in an orifice of the patient's body and under the mucosa orintraluminar outside the mucosa of the orifice.
 142. An apparatusaccording to claim 30, wherein the energy transforming device is adaptedto transform the energy of the first form directly or indirectly intothe energy of the second form.
 143. An apparatus according to claims 28or 29, wherein the apparatus further comprises at least one implantablesensor for sensing at least one physical parameter of the patient. 144.An apparatus according to claim 143, wherein the sensor comprises apressure sensor for directly or indirectly sensing as the physicalparameter the pressure in the urine passageway or the pressure againstthe urethra or the lower part of the urine bladder.
 145. An apparatusaccording to claim 143, further comprising a control device forcontrolling the restriction device in response to signals from thesensor.
 146. An apparatus according to claim 145, wherein the controldevice comprises an internal control unit implantable in the patient forcontrolling the restriction device in response to signals from thesensor.
 147. An apparatus according to claim 146, wherein the internalcontrol unit directly controls the restriction device in response tosignals from the sensor.
 148. An apparatus according to claim 145,wherein the control device comprises an external control unit outsidethe patient's body for controlling the restriction device in response tosignals from the sensor.
 149. An apparatus according to claim 148,wherein the external control unit stores information on the physicalparameter sensed by the sensor and is manually operated to control therestriction device based on the stored information.
 150. An apparatusaccording to claim 143, further comprising at least one implantablesender far sending information on the physical parameter sensed by thesensor.
 151. An apparatus according to claims 28 or 29, furthercomprising implantable electrical components including a single voltagelevel guard.